At Capgemini Engineering we value excellence, care, responsibility, dynamism, and innovation. We offer a job with variation that leaves plenty of room for initiative and development. Indeed, we are not just offering you a job, we’re inviting you to be part of our community where we will provide you trainings, tools & grounds for professional and personal growth. Each career experience is assorted by an attractive salary package.
If you are a team player, if you recognize yourself in this profile and are not afraid of taking on challenges… Apply today!
You will give quality assurance oversight (IQOQ / PQ / PV…)
You will help define and support the Validation Approach,
You will establish procedures for Validation in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP),
You will write and approve validation documents (GMP requirements, protocols, reports, SOPs, Critical Impact Assessments, …)
You will make sure that production practice are aligned with validation conclusion
You will communicate to management about issues in the validation process
You will attend project meetings
You will provide QA oversight and approve deviation
You will pro-actively identify potential quality and compliance risks by managing these risks through the risk register and quality plan process
You will define validation strategies through the change control process
You will write and implement validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review, ….)
You will ensure the correct application of the validation quality systems in the field and define an improvement plan as required
You will support the production, QA and technical service teams in the implementation of validation activities
Master’s degree in (Bio-)engineering, Chemistry, Pharmacy or related scientific domains,
French or Dutch fluent and fluent in English,
A minimum relevant experience of 3 years in the (bio)pharmaceuticals, medical devices or biotechnology sector
Knowledge of GMP / CFR / Eudralex and the different regulations / standards related to validation activities are a big plus
Good interpersonal relationship skills,
Problem solving and achievement oriented,
Be a good team player in order to succeed in each validation project,
World leader in engineering and R&D services, Capgemini Engineering combines its broad industry knowledge and cutting-edge technologies in digital and software to support the convergence of the physical and digital worlds. Coupled with the capabilities of the rest of the Group, it helps clients to accelerate their journey towards Intelligent Industry. Capgemini Engineering has more than 55,000 engineer and scientist team members in over 30 countries across sectors including Aeronautics, Space, Defense, Naval, Automotive, Rail, Infrastructure & Transportation, Energy, Utilities & Chemicals, Life Sciences, Communications, Semiconductor & Electronics, Industrial & Consumer, Software & Internet.
Capgemini Engineering is an integral part of the Capgemini Group, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided every day by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organization of over 340,000 team members in more than 50 countries. With its strong 55-year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2021 global revenues of €18 billion.